NCT04330482

Translating a Dementia Caregiver Intervention Into a Mobile Application

Completed NA Results posted Last updated 28 September 2023

What this trial tests

NA trial testing CARE-Well App in Dementia in 40 participants. Completed in 30 May 2022.

Timeline

13 January 2020

Primary endpoint
30 May 2022

30 May 2022

Quick facts

Lead sponsor	Rhode Island Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	13 January 2020
Primary completion	30 May 2022
Estimated completion	30 May 2022
Sites	2 locations across United States

Drugs / interventions tested

• CARE-Well App
• Internet Links

Conditions studied

• Dementia — all drugs for Dementia →
• Alzheimer Disease — all drugs for Alzheimer Disease →
• Caregiver Burnout — all drugs for Caregiver Burnout →

Sponsor

Rhode Island Hospital

Who can join

18 and older, any sex, with Dementia or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Randomization Primary · 3 months

Percentage of participants who decline participation because of randomization.

Group	Value	95% CI
Internet Links	0
CARE-Well App	0

Study Enrollment Rate and Retention Primary · 3 months

Percentage of participants enrolled and who remain enrolled for the duration of the study.

Group	Value	95% CI
Internet Links	18
CARE-Well App	16

Intervention Adherence Primary · 3 months

Percentage of participants who used the internet links or the app for the 3-month intervention period.

Group	Value	95% CI
Internet Links	18
CARE-Well App	16

Timing of Assessments Primary · 3 months

Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study.

Group	Value	95% CI
Internet Links	18
CARE-Well App	16

Completion Rates Primary · 3 months

Percentage of participants who completed the intervention.

Group	Value	95% CI
Internet Links	18
CARE-Well App	16

Interest in Continuation of Tablet/App Use After Formal Trial Primary · 3 months

Percentage of participants in a subset of caregivers (10 from each group) interested in continuing to use tablet/App use after formal trial as an estimate of sustainability.

Group	Value	95% CI
Internet Links	10
CARE-Well App	10

App Technology Satisfaction Primary · 3 months

Percentage of participants satisfied or very satisfied with App technology.

Group	Value	95% CI
Internet Links	13
CARE-Well App	12

App Content Satisfaction Primary · 3 months

Percentage of participants satisfied or very satisfied with App content.

Group	Value	95% CI
Internet Links	13
CARE-Well App	11

Center for Epidemiologic Studies Depression Scale Secondary · Baseline and immediately Post-Intervention at 3 months

Depression scale; 0-30 points; higher scores indicate worse outcome.

Baseline

Group	Value	95% CI
Internet Links	13.29	± 7.88
CARE-Well App	13.94	± 12.19

Post-Intervention

Group	Value	95% CI
Internet Links	16.71	± 8.36
CARE-Well App	17.38	± 11.67

Zarit Burden Interview Secondary · Baseline and immediately Post-Intervention at 3 months

Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.

Baseline

Group	Value	95% CI
Internet Links	55.53	± 9.82
CARE-Well App	56.56	± 14.40

Post Intervention

Group	Value	95% CI
Internet Links	58.11	± 10.93
CARE-Well App	57.56	± 13.22

Revised Memory and Behavior Problem Checklist Secondary · Baseline and immediately Post-Intervention at 3 months

Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes.

Baseline

Group	Value	95% CI
Internet Links	22.88	± 7.90
CARE-Well App	22.00	± 8.61

Post Intervention

Group	Value	95% CI
Internet Links	18.10	± 10.56
CARE-Well App	11.56	± 16.91

Desire to Institutionalize Scale Secondary · Baseline and immediately Post-Intervention at 3 months

Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize).

Baseline

Group	Value	95% CI
Internet Links	0.82	± 1.24
CARE-Well App	1.38	± 1.45

Post Intervention

Group	Value	95% CI
Internet Links	1.12	± 1.54
CARE-Well App	1.94	± 2.29

Sponsor's own description

The overall goal of this development project is to combine elements of two efficacious interventions into a mobile health (mHealth) App for informal dementia caregivers. The investigators will conduct a 3-month feasibility trial of the newly-developed CARE-Well App in 40 dementia caregivers to establish acceptability and feasibility of the intervention, study procedures, and outcome measures.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Remotely delivered information, training and support for informal caregivers of people with dementia.
   González-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozúa B, et al · · 2021 · cited 54× · PMID 33417236 · DOI 10.1002/14651858.cd006440.pub3